Can anyone please direct me to where in the guidance or legislation it gives a timeline for updating corporate websites with PV information such as a safety update of an SmPC? The GPvP module XV B.5.5 just states “Information on websites should be kept up-to-date, with any information that is out-of-date marked as such or removed.” There are no timelines given and I cannot find any MHRA guidance on the topic.
I was also wondering from your experience and discussions with others, is the GVP purple guide still widely referred to to keep up to date with MHRA guidance? My colleagues and I find that it seems to be the most useful source material however it is obviously 11 years old now.
Dear PIPA Member
Thank you for your enquiry.
Please note that the response to your query represents the views and suggestions of the PIPA Committee Members and are intended as guidance only. Please refer to the applicable Pharmacovigilance legislation, guidelines and your own company procedures.
The timeline for the upload of PV / Reference Safety Information (RSI) e.g. Summary of Product Characteristics (SmPC) onto a digital platform such as a corporate website is not defined in the UK regulations explicitly.
It is the experience of the PIPA Committee members that such an update is usually made in accordance with internal company procedures and / or at the time an update is provided to the Electronics Medicines Compendium (https://www.medicines.org.uk/emc/about-the-emc#anchor4). The expectation of the emc is as follows:
“How is the information updated?
When there is new information about a medicine, or when a new medicine is launched, the pharmaceutical company should update emc website within 10 days of the UK or European medicines authority approving the change”.
Secondly, as the Good Pharmacovigilance Practice Guide (MHRA Purple Guide) was published in 2009/2010, PIPA members utilise it in conjunction with the EMA’s GVP Modules, which will remain in force until the MHRA publish a guidance note on the exceptions and modifications in due course. Please refer to: https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-from-1-january-2021/updated-guidance-on-pharmacovigilance-procedures
We do hope the above answers your queries.
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